22nd Century Files Premarket Tobacco Application (PMTA) with the FDA
December 05 2018 - 9:00AM
Business Wire
A PMTA is an important first step toward
achieving potentially the first – and only – Modified Risk Tobacco
Product marketing order for a combustible cigarette
22nd Century Group, Inc. (NYSE American:XXII), a plant
biotechnology company focused on tobacco harm reduction and Very
Low Nicotine tobacco, today submitted a Premarket Tobacco
Application (PMTA) with the U.S. Food and Drug Administration (FDA)
seeking authorization to commercialize the Company’s “BRAND A”
cigarette products under the proposed brand name VLNTM (the product
name is subject to FDA approval). 22nd Century’s proposed VLNTM
cigarettes – the subject of the PMTA – are made with 22nd Century’s
proprietary VLNTM tobacco and, as a result, contain very low levels
of nicotine.
A PMTA marketing order is a prerequisite to commercializing any
new tobacco product in the United States. The Company’s PMTA
submission precedes the forthcoming filing of the separate, more
comprehensive Modified Risk Tobacco Product (MRTP) application for
22nd Century’s proposed VLNTM premium cigarettes. 22nd Century’s
MRTP application will request FDA authorization for the Company to
state on packaging and advertising that, among other things, the
proposed VLNTM cigarettes contain just 0.5mg nicotine per gram of
tobacco. In contrast, a survey of the top 100 leading cigarette
brands in the United States showed that conventional and highly
addictive cigarettes currently sold in the United States contain an
average of 19.4mg of nicotine per gram of tobacco (with an actual
nicotine range of 14.7mg to 33.2mg per gram of tobacco).
22nd Century’s proposed VLNTM cigarettes are modeled after the
Company’s Very Low Nicotine Content (VLNC) SPECTRUM® research
cigarettes. 22nd Century’s PMTA for the proposed VLNTM brand
cigarettes references more than 50 independent studies conducted
using the Company’s proprietary SPECTRUM® research cigarettes. The
World Health Organization (WHO) Study Group on Tobacco Product
Regulation has recommended that all member countries limit the
nicotine content of cigarettes to the level found in VLNC SPECTRUM®
cigarettes. (WHO Global Nicotine Reduction Strategy)
In March 2018, the FDA announced its plan to issue a proposed
rule that, when finalized and effective, would limit the amount of
nicotine in all cigarettes sold in the United States to minimally
or non-addictive levels. In October 2018, Dr. Lynn Hull, Lead
Pharmacologist at the Division of Individual Health Science within
the FDA’s Center for Tobacco Products, held a webcast highlighting
and summarizing the published science surrounding VLNC cigarettes.
During the webcast, Dr. Hull indicated a minimally non-addictive
level of nicotine in cigarettes could be approximately between
0.2mg to 0.7mg nicotine per cigarette.
“Later this month, 22nd Century will submit to the FDA the
Company’s highly-anticipated MRTP application. Containing only a
tiny fraction of the nicotine found in the 100 leading U.S.
cigarette brands, 22nd Century’s proposed VLNTM cigarettes will
demonstrate conclusively that the FDA’s plan to dramatically reduce
nicotine in all U.S. cigarettes is immediately feasible,” explained
Henry Sicignano, Chief Executive Officer and President at 22nd
Century Group. “As potentially the first – and only – combustible
cigarettes to achieve a marketing order from the FDA under the MRTP
program, 22nd Century’s proposed VLNTM cigarettes will provide
smokers with a nearly nicotine-free choice… and will change the
tobacco industry forever.”
About SPECTRUM® Research Cigarettes
22nd Century developed SPECTRUM® research cigarettes in
collaboration with independent researchers and officials from the
National Institute on Drug Abuse (NIDA), the U.S. Food and Drug
Administration (FDA), the National Cancer Institute (NCI), and the
Centers for Disease Control and Prevention (CDC). Produced
exclusively by 22nd Century with the Company’s proprietary VLNTM
tobacco plants, very low nicotine SPECTRUM® cigarettes are the
foundation for important nicotine reduction public policy
initiatives around the world. The main SPECTRUM® product line
consists of a series of cigarette styles that vary in nicotine
yields from very low to relatively high nicotine. 22nd Century
supplies SPECTRUM® research cigarettes in 24 styles, in both
regular and menthol versions, with 8 different levels of
nicotine.
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company focused on
technology which allows the increase or decrease in the level of
nicotine in tobacco plants and the level of cannabinoids in
hemp/cannabis plants through genetic engineering and plant
breeding. The Company’s primary mission in tobacco is to reduce the
harm caused by smoking. The Company’s primary mission in
hemp/cannabis is to develop proprietary hemp/cannabis strains for
important new medicines and agricultural crops. Visit
www.xxiicentury.com and www.botanicalgenetics.com for more
information.
Cautionary Note Regarding Forward-Looking Statements: This press
release contains forward-looking information, including all
statements that are not statements of historical fact regarding the
intent, belief or current expectations of 22nd Century Group, Inc.,
its directors or its officers with respect to the contents of this
press release, including but not limited to our future revenue
expectations. The words “may,” “would,” “will,” “expect,”
“estimate,” “anticipate,” “believe,” “intend” and similar
expressions and variations thereof are intended to identify
forward-looking statements. We cannot guarantee future results,
levels of activity or performance. You should not place undue
reliance on these forward-looking statements, which speak only as
of the date that they were made. These cautionary statements should
be considered with any written or oral forward-looking statements
that we may issue in the future. Except as required by applicable
law, including the securities laws of the United States, we do not
intend to update any of the forward-looking statements to conform
these statements to reflect actual results, later events or
circumstances, or to reflect the occurrence of unanticipated
events. You should carefully review and consider the various
disclosures made by us in our annual report on Form 10-K for the
fiscal year ended December 31, 2017, filed on March 7, 2018,
including the section entitled “Risk Factors,” and our other
reports filed with the U.S. Securities and Exchange Commission
which attempt to advise interested parties of the risks and factors
that may affect our business, financial condition, results of
operation and cash flows. If one or more of these risks or
uncertainties materialize, or if the underlying assumptions prove
incorrect, our actual results may vary materially from those
expected or projected.
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version on businesswire.com: https://www.businesswire.com/news/home/20181205005171/en/
22nd Century GroupJames Vail, Director of
Communications716-270-1523jvail@xxiicentury.com
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